@ CURIOAbout the Curio Curio Training and Research Institute (CTRI) is the Constituent Unit of CliMed Research Solutions India, dedicated to providing Pharma and Healthcare industry Training. Curio is established to transform the pharma and healthcare landscape by nurturing talent, fostering innovation, and driving excellence in these critical sectors. Curio commits to producing professionals well-versed in theory and equipped with practical skills to lead, innovate, and create positive change. Curio provides industryoriented value-added, skill development courses, corporate training, and career consultation to individuals and institutions/ universities. About the Course Pharmacovigilance is a field of science that primarily deals with determining, verifying, quantifying, analyzing, and reducing the ill effects of medical drugs, devices, or biologicals, thus ensuring their Peano net eM Mog ea MLS Ge komen eee Ree} CN Re ete aa Cut Rn re ea ek Re oe eo Curio’s Executive Diploma in Pharmacovigilance & Drug Safety program is devised to meet the increasing demand by the industry for drug safety and quality assurance professionals. The program eee ca hey ome Ret Aenea Ae ce Sonne eens) of core quality assurance methods, processes, and practices. The program enables the professional eee Sia hetie eta atoe euree url eet elke Mees Rae Racy cir Rees ens one el eee heat os(Cemented f Mock Interviews & Exclusive (4+2) Course Design 2) " J f Soft-skill Development Sessions J Comprehensiveness with Course Material Book will be delivered a wide coverage Doorsteps for Free Affordable price with 100% Live classes with real-time query numerous discount facilities resolution & end-to-end engagement Leadership Dialogues (Live virtual interaction with A-level corporates and academicians) ~ A Who can Attend? ‘> Beginners to develop an understanding of Pharmacovigilance ‘> Intermediate to Improve the Skills > Pharmacy/Life sciences/Medical/Dental/Nursing Students/Professionals irrespective of their year of study and course ‘=> Student/academician/industry delegates ‘> Anyone who wants to learn PharmacovigilanceSyllabus of the Course 1. 2 3. 4. Introduction to Pharmacovigilance. Basics of Pharmacovigilance International Pharmacovigilance and Safety Regulations Methodologies in Pharmacovigilance- 1(e.g., Active/ passive surveillance, spontaneous reports, case series etc.) - Methodologies in Pharmacovigilance- 2 (e.g., Drug event monitoring, registries, cross-sectional, case-control, descriptive, cohort & comparative observational studies, etc.) Case processing in Pharmacovigilance (Triage, DE, QC, MR, and Submission) Seriousness, expectedness, and Causality assessment criteria Key documents in Pharmacovigilance Pharmacovigilance Programme in India (PVPI) 10. Signal detection and analysis 11. Adverse drug reaction reporting system 12. PV Drug Dictionaries (MedDRA & WHO Dictionaries etc.) 13. ICH & other regulatory requirements for drug safety (E2) 14. Periodic Safety Update Report (PSUR) and other Aggregate Safety Reports 15. Pharmacovigilance data management & safety monitoring 16. Pharmacovigilance compliance 17. Audits & Inspections in PV 18. Introduction to PV software (ARGUS & ArisG) 19. Case study/training on case processing & report generation 20. Career guidance- interview tips 21. The regulatory process for Medical Devices OVA EL EEN ES eae ava Cl Led a eect YE LMR ee gee ae eee Maen reed are from top-notch industries & institutions with multiple years of nae Pe Ae neg eer EM TT Deeg eA eTMode of Course: Duration of the course: oo] Oo] Online Six months = Classes: Course Commencement: Weekend Evening November 30, 2024 Classes Live Eu Course Fees: Last Date of Registration: Registration Link 3,999/- INR cow cw [EZ November 17, 2024 https://rzp.io//cupvoc introductory ascount on 7999/) Certifcate will be given to all participants based on the performance in in-course assignment & quizzes. Course Convener Dr. Ajit Singh 4 CEO and Founder, CliMed Research Solutions & Curio Research Scientist for ICMR, Department of Medicine, Kasturba Medical College & Hospital, MAHE Dr. Ajit Singh, Founder, and chief Executive Officer at CliMed Research Solutions & Curio - India, a young entrepreneur & scientist, has completed his Ph.D. in Cardiology from the eminent Manipal ‘Academy of Higher Education (MAHE), a leading organization in research and education in India. Recently, he was appointed as Research Scientist & RAIl| for ICMR" at the Department of Medicine, Kasturba Medical College, Manipal. He also serves as ‘National Director for Research’ at 'World Youth Heart Federation’ (WYHF-India) & ‘Principal Investigator for ‘Manipal Heart Failure Registry (MHER). In July 2021, he was appointed as Vice president of the Medical Artificial Intelligence Wing at Idika Al, Mumbai. He has published more than 40 papers in different streams of medicine, including Cardiology, Cardio- oncology, and Infectious Diseases. He is the investigator and site coordinator for many international clinical trials. Dr. Singh is an honorary reviewer in many reputed journals, including Oxford Group, BM Group, and Spriner Group of Journals. Dr. Singh has been appointed as Editor-in-chief for the Journal of Basic and Clinical Cardiovascular Research and an editorial board member for several medical jour- nals. He has received several international research and travel grants from esteemed organizations, including the European Society of Cardiology, the Indian Council for Medical Research, DST-SERB, and the American College of Cardiology. He received the 'Young Achievers Award 2019! and 'Yung Scientist ‘Award 2020’ in Cardiology Research from reputed international organizations. Dr. Singh has traveled to more than ten countries regarding his research presentations and invited lectures. 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